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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Hainan Poly Pharm. Co Ltd

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    HAINAN POLY PHARM. CO LTD

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    Hainan Poly Pharm
    China Flag
    Country
    Country
    China
    Address
    Address
    Guilingyang Economic Development Area, Haikou, Hainan 571127
    Telephone
    Telephone
    +86 571-89385087
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    Email
    enquiries@pharmacompass.com
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    https://www.hnpoly.com/en/
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    Amiodarone Hydrochloride

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    USDMF

    Found USDMF

    36163
    Active
    AMIODARONE HYDROCHLORIDE USP
    2021-09-07
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-481 - Rev 00
    Valid
    Amiodarone hydrochloride
    2023-03-09
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    36163
    R0-CEP 2021-481 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    AMIODARONE HYDROCHLORIDE USP
    Amiodarone hydrochloride
    Issue/Submission Date
    2021-09-07
    2023-03-09
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    Dobutamine Hydrochloride

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    USDMF

    Found USDMF

    35217
    Active
    DOBUTAMINE HYDROCHLORIDE USP
    2020-09-27
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-415 - Rev 00
    Valid
    Dobutamine hydrochloride
    2021-09-22
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    35217
    R0-CEP 2020-415 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DOBUTAMINE HYDROCHLORIDE USP
    Dobutamine hydrochloride
    Issue/Submission Date
    2020-09-27
    2021-09-22
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    Esomeprazole Sodium

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    USDMF

    Found USDMF

    35059
    Active
    ESOMEPRAZOLE SODIUM
    2020-08-13
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-351 - Rev 00
    Valid
    Esomeprazole sodium
    2021-10-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35059
    R0-CEP 2020-351 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ESOMEPRAZOLE SODIUM
    Esomeprazole sodium
    Issue/Submission Date
    2020-08-13
    2021-10-15
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    Glycopyrronium Bromide

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    USDMF

    Found USDMF

    35446
    Active
    GLYCOPYRROLATE
    2021-05-13
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-154 - Rev 00
    Valid
    Glycopyrronium bromide
    2022-11-16
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    35446
    R0-CEP 2021-154 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    GLYCOPYRROLATE
    Glycopyrronium bromide
    Issue/Submission Date
    2021-05-13
    2022-11-16
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    Magnesium Hydroxide

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    USDMF

    Found USDMF

    36567
    Active
    MAGNESIUM HYDROXIDE USP
    2021-12-16
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-010 - Rev 00
    Valid
    Magnesium Hydroxide
    2022-07-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36567
    R0-CEP 2022-010 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MAGNESIUM HYDROXIDE USP
    Magnesium Hydroxide
    Issue/Submission Date
    2021-12-16
    2022-07-26
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    • FDA
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    Sodium Nitroprusside

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    USDMF

    Found USDMF

    33023
    Active
    SODIUM NITROPRUSSIDE USP
    2018-09-06
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-114 - Rev 01
    Valid
    Sodium nitroprusside
    2022-03-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33023
    R0-CEP 2020-114 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SODIUM NITROPRUSSIDE USP
    Sodium nitroprusside
    Issue/Submission Date
    2018-09-06
    2022-03-14
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    Desloratadine

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    USDMF

    Caution USDMF

    23926
    Inactive
    DESLORATADINE
    2010-06-25
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-174 - Rev 01
    Valid
    Desloratadine
    2022-03-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23926
    R0-CEP 2018-174 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DESLORATADINE
    Desloratadine
    Issue/Submission Date
    2010-06-25
    2022-03-16
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    Acyclovir Sodium

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    USDMF

    Found USDMF

    35112
    Active
    ACYCLOVIR SODIUM DRUG SUBSTANCE
    2020-08-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35112
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ACYCLOVIR SODIUM DRUG SUBSTANCE
    Issue/Submission Date
    2020-08-31
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    Apremilast

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    USDMF

    Found USDMF

    38437
    Active
    APREMILAST
    2023-08-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38437
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    APREMILAST
    Issue/Submission Date
    2023-08-15
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    Crisaborole

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    USDMF

    Found USDMF

    39148
    Active
    CRISABOROLE
    2023-11-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39148
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CRISABOROLE
    Issue/Submission Date
    2023-11-30
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    Gadoterate Meglumine

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    USDMF

    Found USDMF

    37072
    Active
    GADOTERATE MEGLUMINE
    2022-05-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    37072
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GADOTERATE MEGLUMINE
    Issue/Submission Date
    2022-05-31
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    Gadoteridol

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    USDMF

    Found USDMF

    37960
    Active
    GADOTERIDOL USP
    2023-02-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    37960
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GADOTERIDOL USP
    Issue/Submission Date
    2023-02-09
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    Memantine Hydrochloride

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    USDMF

    Found USDMF

    34870
    Active
    MEMANTINE HYDROCHLORIDE, USP
    2020-05-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34870
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MEMANTINE HYDROCHLORIDE, USP
    Issue/Submission Date
    2020-05-29
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    Memantine Hydrochloride

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    USDMF

    Found USDMF

    37704
    Active
    MEMANTINE HYDROCHLORIDE USP
    2022-11-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37704
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MEMANTINE HYDROCHLORIDE USP
    Issue/Submission Date
    2022-11-29
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    Tecovirimat

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    USDMF

    Found USDMF

    38852
    Active
    TECOVIRIMAT MONOHYDRATE
    2023-09-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38852
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TECOVIRIMAT MONOHYDRATE
    Issue/Submission Date
    2023-09-20
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    Trimebutine Maleate

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    USDMF

    Found USDMF

    34948
    Active
    TRIMEBUTINE MALEATE DRUG SUBSTANCE
    2020-06-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34948
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TRIMEBUTINE MALEATE DRUG SUBSTANCE
    Issue/Submission Date
    2020-06-24
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    • FDA
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    VORICONAZOLE USP

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    USDMF

    Found USDMF

    38466
    Active
    VORICONAZOLE USP
    2023-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38466
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    VORICONAZOLE USP
    Issue/Submission Date
    2023-09-01
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    GADOBUTROL USP

    PDF Supplier PDF
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    USDMF

    Found USDMF

    39149
    Active
    GADOBUTROL USP
    2023-11-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39149
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GADOBUTROL USP
    Issue/Submission Date
    2023-11-30
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    • FDA
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    Aspirin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    23734
    Inactive
    ASPIRIN AND DIPYRIDAMOLE EXTENDED R...
    2010-04-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23734
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    ASPIRIN AND DIPYRIDAMOLE EXTENDED R...
    Issue/Submission Date
    2010-04-14
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    • FDA
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    Azithromycin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    23486
    Inactive
    AZITHROMYCIN GRANULES FOR ORAL SUSP...
    2010-01-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23486
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    AZITHROMYCIN GRANULES FOR ORAL SUSP...
    Issue/Submission Date
    2010-01-27
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    Diclofenac Sodium

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    23243
    Inactive
    DICLOFENAC SODIUM EXTENDED RELEASE ...
    2009-11-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23243
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DICLOFENAC SODIUM EXTENDED RELEASE ...
    Issue/Submission Date
    2009-11-02
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    Felodipine

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    USDMF

    Caution USDMF

    23724
    Inactive
    FELODIPINE EXTENDED RELEASE TABLETS
    2010-04-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23724
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    FELODIPINE EXTENDED RELEASE TABLETS
    Issue/Submission Date
    2010-04-14
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    Ganciclovir Sodium

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    USDMF

    Caution USDMF

    25122
    Inactive
    GANCICLOVIR SODIUM
    2011-07-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25122
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    GANCICLOVIR SODIUM
    Issue/Submission Date
    2011-07-13
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    Glucosamine Hydrochloride

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    USDMF

    Caution USDMF

    23487
    Inactive
    GLUCOSAMINE HYDROCHLORIDE PELLETS C...
    2010-01-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23487
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    GLUCOSAMINE HYDROCHLORIDE PELLETS C...
    Issue/Submission Date
    2010-01-27
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    Metformin

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    USDMF

    Caution USDMF

    23726
    Inactive
    METFORMIN HYDROCHLORIDE EXTENDED RE...
    2010-04-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23726
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    METFORMIN HYDROCHLORIDE EXTENDED RE...
    Issue/Submission Date
    2010-04-14
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    Theophylline

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    23244
    Inactive
    THEOPHYLLINE EXTENDED RELEASE CAPSU...
    2009-11-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23244
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    THEOPHYLLINE EXTENDED RELEASE CAPSU...
    Issue/Submission Date
    2009-11-02
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    Trimebutine Maleate

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    USDMF

    Caution USDMF

    23725
    Inactive
    TRIMEBUTINE MALEATE TABLETS
    2010-04-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23725
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TRIMEBUTINE MALEATE TABLETS
    Issue/Submission Date
    2010-04-14
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    Trimebutine Maleate

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    USDMF

    Caution USDMF

    24203
    Inactive
    TRIMEBUTINE MALEATE DRUG SUBSTANCE
    2010-08-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24203
    Status
    Inactive
    Fees Paid
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